Scancell says it is just weeks away from enrolling patients into its phase 2 trial of melanoma drug SCIB1, its lead T-cell boosting immunotherapy, in the UK.
The UK biotech – founded by renowned immunologist Lindy Durrant – laid out the timeline in a mid-year update on its activities, saying that the regulatory and ethical approvals for the trial are in place and the clinical trial centres are ready to start recruitment.
SCIB1 is the lead programme from Scancell’s ImmunoBody platform, a plasmid DNA-based vaccine approach that is designed to recruit and activate cell-killing CD8 T cells. Unlike other cancer vaccine technologies ImmunoBodies can target dendritic cells, which means they can generate a broader immune response to tumours, according to Scancell.
The drug has already been through a phase 1/2 trial in around 35 patients with melanoma, generating preliminary signs of efficacy as well as an acceptable safety profile.
In the US, the start of clinical testing for SCIB1 is pending the outcome of discussions with the FDA about the technology used to deliver the immunotherapy, that have been going on now for several months.
Licensed from Ichor Pharma, the TriGrid electroporation delivery system uses electrical pulses to open pores in cell membranes and allow plasmid entry. The FDA has raised questions about the delivery device that will have to be resolved before a planned phase 2 trial of SCIB1 with a checkpoint inhibitor can get underway.
Scancell chief executive Dr Cliff Holloway said the SCIB1 development was part of a “busy and productive” six months for the company that also included the development of a new formulation of SCIB2, its second ImmunoBody partnered with Cancer Research UK.
A phase 1/2 trial in solid tumours is at the planning stage and will make use of the new liposomal nanoparticle formulation of the drug, which targets the NY-ESO-1 antigen.
Meanwhile, Scancell’s Moditope platform – which zeroes in on molecular changes in stressed cells – is also making progress. The aim is to identify antigens that appear in cells in a stressed state, such as those that are cancerous, and generate vaccines against them.
Lead candidate Modi-1 has been synthesised at scale by contract manufacturer Polypeptide Group in the Netherlands and formulation work is now ongoing to prepare for preclinical and clinical trials.
Holloway also highlighted the establishment of a clinical advisory board as the company looks ahead to having multiple drugs in the clinic, as well as a £3.9m cash injection from new investor Vulpes Life Sciences last month. Martin Diggle, co-founder of Vulpes, has been appointed a non-executive director of Scancell.